ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

Tongji Hospital

Status and phase: Completed; Phase 4

Conditions: Elective Surgery

Treatments: Drug: fospropofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06344325

EDPP

Details and patient eligibility

About

Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia

Full description

As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.

Enrollment: 330 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-80 years old, elective surgery under general anesthesia.
• ASA I-II;
• Surgical duration>30 minutes;
• Sign an informed consent form.

Exclusion criteria

• American Society of Anesthesiologists(ASA)≥ III;
• Body mass index (BMI)<18 kg/m2 or>30 kg/m2;
• Individuals with a history or potential history of drug abuse or alcohol dependence;
• Preoperative use of sedative or analgesic drugs;
• Individuals with severe liver and kidney dysfunction;
• Individuals who are allergic or potentially allergic to propofol and lipids;
• The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures;
• Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status;
• Participants in other clinical studies within the past 3 months;
• researchers deemed it inappropriate for participants to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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330 participants in 3 patient groups

Youth group

Experimental group

Description:

Youth group (18-45 years old)

Treatment:

Drug: fospropofol

middle-aged group

Experimental group

Description:

middle-aged group (46-65 years old)

Treatment:

Drug: fospropofol

elderly group

Experimental group

Description:

elderly group (66-80 years old)

Treatment:

Drug: fospropofol